BEUDAMED
    Product Code: JPJ FDA class 2 21 CFR 864.5300

    Red-Cell Indices, Calculated

    Hematology

    The Red-Cell Indices, Calculated device is a hematology diagnostic system that automatically calculates mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) from measured hematological parameters, providing indices that assist in the morphological classification of anemias and other blood disorders. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JPJ and is regulated under 21 CFR 864.5300, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    14

    Basic Information

    Product Code
    JPJ
    Device Class
    FDA class 2
    Regulation Number
    864.5300
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K904675 QBC SYSTEM MCHC
    K780946 ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
    K761304 JTB 700 HEMATOLOGY ANALYZER